N/A
N=31
Nasal Bridles and Repeat Endoscopic Procedures for Endoscopic Nasoenteric Tubes
Feeding Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03966157 ↗Enrolled (actual)
31
Serious AEs
0.0%
Results posted
May 2023
Primary outcome: Primary: Repeat Endoscopy to Replace Dislodged Feeding Tube — 3; 2 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Nasal Bridle (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- St. Louis University
- Primary completion
- Mar 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Repeat Endoscopy to Replace Dislodged Feeding Tube |
3; 2 | — |
| SECONDARY Inadvertent Tube Dislodgement |
7; 2 | — |
Summary
In critically ill patients, nutrition is a major part of healing and recovery. In patients unable to tolerate oral feeding, nasoenteric tube feeding (a tube placed from the nose to the stomach or small intestine) provides a safe alternative for feeding. Some patients require these tubes to be placed endoscopically due to numerous patient factors including difficult anatomy, need for post-gastric feeding, among others). In patients that require endoscopically placed tubes, there is risk of perforation, infection, bleeding, aspiration, and rarely even death. In patients that have recurrent dislodgement of endoscopically placed tubes, the need for repeat endoscopy increases patient exposure to these risks. Traditional securing mechanism with adhesive tape to reduce dislodgment often fail in critically ill patients requiring patients to have repeat endoscopies to replace nasoenteric feeding tubes and subjects patients potentially to increased cumulative risks associated with each endoscopy.
The investigators propose to collect data for one year, the investigators will prospectively follow via chart review endoscopically placed naso-enteric tubes placed with a Standard AMT Bridle securement device and assess if there is a reduction in accidental tube removal requiring replacement endoscopically.
Eligibility Criteria
Inclusion Criteria
- Patients in need for endoscopically placed nasoenteric feeding tube
Exclusion Criteria
- Age greater than 90 years
Data sourced from ClinicalTrials.gov (NCT03966157). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.